The multicenter, randomized, parallel controlled clinical trail of evaluation of safety and efficacy of Carbon Nanoparticles Suspension Injection in treatment of colorectal cancer surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-OPR-17012049

Enrollment

Unknown

Registered

2017-07-19

Start date

2017-03-22

Completion date

Unknown

Last updated

2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

test group:inject Carbon Nanoparticles Suspension preoperatively

Control:Blank

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Colorectal cancer was confirmed by colonoscopy and pathology preoperatively; 2. Operation requirements: laparoscopic/open colon/rectal cancer radical surgery; 3. Aged 18 to 70 years; 4. Preoperative laboratory results meet the following conditions: ANC = 1.5 x 10^9/L, PLT = 100 x 10^9/L, TBI = 1.5 x upper normal limit (2 mg/dl), ALT, AST = 2 x upper normal limit, coagulation parameters in normal range; 5. Patients have no psychological, family, social or geographica constraints on compliance and follow-up; 6. Patients signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other types of colorectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumor, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma); 2. History of abdominal surgery; 3. Received preoperative neoadjuvant therapy, including radiotherapy and chemotherapy; 4. Inable to inject carbon nanoparticles preoperatively due to various reasons; 5. Not radical surgery; 6. Ileus, strangulation, peritonitis, etc; 7. With distal metastasis 8. Severe cardiopulmonary or hepatorenal disorders, can not tolerate surgery; 9. Active liver disease or liver function is abnormal, ALT, AST, TBIL = 2 x upper normal limit; 10. Renal impairment, Cr = 2 x upper normal limit or BUN = 2 x upper normal limit; 11. WBC < lower normal lower limit or PLT < lower normal limit, or have other blood system diseases; 12. Have mental disorder or mental retardation and cannot correctly describe their feelings; 13. Serious coagulation disorder, bleeding tendency; 14. Uncontrolled internal disease, history of myocardial infarction (3 months), acute infection; 15. Uncontrolled serious hypertension and diabetes; 16. Allergic to the test drug; 17. With alcohol or drug abuse history; 18. Participants of drug tests attended within 3 months; 19. Researchers think not suitable for this trail.

Design outcomes

Primary

Measure	Time frame
count of lymph nodes;count of positive lymph nodes;	—

Countries

China

Contacts

Public ContactXinxiang Li

Fudan University Shanghai Cancer Center

lxx1149@163.com+86 13761291659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026